Cleveland BioLabs: reports the Quarter & More... $CLBI

Cleveland BioLabs (CBLI): Revenues for 2011 were $9M, (versus $15M in 2010) this was a result of the difference in US biodefense revenues (contracts and grants).  Opearting expenses were high at $34M versus $26MM spent in 2010. R&D expenses for the year came in at $22.8MM, up 42% from the $16.1MM spent in 2010 in the year prior. This was directly related to additional (preclinical) animal studies and manufacturing of CBLB502 as well as preparations for human clinical work. G&A expenses were $11M. CBLI ended the year with $28M in cash which is strong for a biodefense company especially since the qtrly cash burn is modest at $3.6-4.2M.

BioDefense Moving Forward: As part of todays news the company announced that last last year the company received a confirmatory letter from the FDA.  The FDA did not have any objections to the development plan for CBLB502 in biodefense. Cleveland BioLabs will now respond to BARDA’s current open Broad Agency Announcement (BAA) by submitting a white paper by year end. A BARDA response should follow (90 days) followed by an invitation to submit a contract proposal.

Clinical Testing of CBLB502 in Oncology: Earlier this month the company announced that the first patient completed a series of five doses in the phase 1 trial evaluating CBLB502 in cancer patients. N=48 patients are expected to be enrolled across several arms to provide data on safety, tolerability, and PKA (dose simetry) as well as hints at efficacy. 

Clevland Bio Labs ($CBLI): Moving beyond BioDefense

Cleveland Biolabs (CBLI): Company is looking at utility of CBLB502 in Cancer Patients:

• The rationale for the trial is based on preclinical studies indicating that CBLB502, (see background below) is a drug under development to reduce the risk of death following exposure to radiation. The compound may have direct anticancer properties when administered as a single agent. This was shown in a number of experimental tumor models in animals, particularly in metastatic nodules in the liver
• Cleveland BioLabs announced that the first patient completed an initial series of 5 doses in a Phase I trial evaluating CBLB502 in advanced cancer patients.
• The study will evaluate the safety and pharmacokinetic profile of CBLB502 in patients with advanced cancers.
• Up to 48 patients are expected to be enrolled in multiple cohorts to determine the safety, tolerability, and maximum tolerated dose of repeated administrations of CBLB502.
• Evaluations for evidence of anticancer activity of CBLB502 in advanced cancer patients will also be performed.

Background: The scientific foundation of Cleveland BioLabs’s product development efforts is based upon proprietary discoveries of the molecular mechanisms underlying a form of cell death called apoptosis. Apoptosis is a highly specific and tightly regulated form of cell death that can be initiated by a variety of external and internal stresses including exposure to radiation or toxic chemicals. For example, exposure to high doses of radiation is lethal due to massive cell loss through apoptosis in radiosensitive tissue such as the hematopoietic (HP) system and the gastrointestinal (GI) tract (“Acute Radiation Syndrome” (ARS)). In addition, apoptotic death of bystander non-tumor cells accounts for the dose-limiting toxicity of anti-cancer radio- and chemotherapy that affects more than 70% of patients. Apoptosis is also a major determinant of tissue damage caused by acute medical conditions involving ischemia (lack of sufficient blood flow) such as cerebral stroke, heart attack and acute renal failure. On the other hand, apoptosis can serve as a protective mechanism that allows the body to rid itself of defective cells, such as those that have gained malignant potential and would develop into tumors if not eliminated. Thus, strategic manipulation of apoptosis has a wide range of potential therapeutic applications.

Based upon research by the founder and Chief Scientific Officer of CBLI, Dr. Andrei Gudkov, we have developed novel proprietary strategies to target the molecular mechanisms controlling apoptotic cell death for therapeutic gain. These strategies exploit naturally occurring differences in the way tumor cells and normal cells respond to genotoxic (DNA-damage-inducing) stresses such as radiation. As illustrated in the Figure below, tumor cells are typically characterized by defects in stress-induced apoptotic pathways. Such defects frequently include inactivation of the p53 tumor suppressor and/or constitutive activation of NF-kappaB signaling. Thus, while normal cells undergo apoptosis in response to radiation, tumor cells die through other non-apoptotic pathways.

CBLI is focused on development of two general classes of apoptosis-modulating pharmaceuticals:

1. Protectans are compounds that block stress-induced apoptosis. Since the targeted pathway is typically only functional in normal cells, Protectans have the potential to specifically protect normal, but not tumor, cells from death in the face of stress. CBLI’s lead Protectan compounds, CBLB502 and CBLB600 Series, are optimized derivatives of microbial factors that are natural regulators of apoptosis. Our expectations for these rationally designed compounds have been borne out in extensive preclinical studies showing that Protectans rescue mammals exposed to lethal doses of radiation by protecting the vulnerable HP and/or GI systems. Protectans may be useful in counteracting the effects of radiation exposure in military, terrorist attack and nuclear accident settings, in protecting cancer patients from the negative side effects of radiation and chemotherapy, and in limiting ischemia-induced tissue damage. CBLI’s recent discovery that CBLB600 Series Protectans also regulate proliferation and mobilization of hematopoietic stem cells opens up another wide array of potential applications for these drugs.
2. Curaxins are small molecules designed to reactivate apoptotic pathways in tumor cells by simultaneously restoring p53 function and inhibiting NF-kappaB activity. Curaxins induce apoptosis in a broad range of human tumor cells, yet have no effect on normal cells. Curaxins also sensitize tumor cells to the apoptosis-inducing effects of other cancer treatments. Thus, Curaxins may be useful either as a monotherapy or as an adjuvant to other therapies for a number of human malignancies including renal cell carcinoma, hormone-refractory prostate cancer, soft-tissue sarcoma and myeloma. CBLI’s first generation Curaxin, CBLC102, has demonstrated safety and activity in a Phase II clinical trial in patients with hormone-refractory prostate cancer. In addition, CBLI has successfully identified a lead next generation Curaxin compounds that have demonstrated reliable anti-tumor effects in animal models of colon, breast, renal and prostate cancers. These next generation compounds have favorable pharmacological characteristics, are suitable for oral administration and demonstrate a complete lack of genotoxicity. They share all of the positive aspects of CBLC102, but significantly exceed the former compound’s activity and efficacy in pre-clinical tumor models. Development of the next generation compounds will be conducted through Incuron, a joint venture between CBLI and BioProcess Capital Ventures.

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An in-depth look at electronics counterfeiting; $APDN

Applied DNA Sciences Inc. (OTCBB: APDN; Twitter: $APDN) sells patented DNA security solutions to protect products, brands and intellectual property from counterfeiting and diversion. SigNature DNA is a botanical mark used to authenticate products in a unique manner that essentially cannot be copied, and provide a forensic chain of evidence that can be used to prosecute perpetrators. Applied DNA Sciences (APDN) is the only company in the world that is making use of the complex codes embedded in botanical DNA as the ultimate solution to counterfeiting.

Between the National Defense Authorization Act for 2012, Amendment 2012 requiring the Pentagon to enact more aggressive procedures and strategies for counterfeit detection, and Applied DNA Sciences' research partnership with University at Albany's College of Nanoscale Science and Engineering (CNSE), counterfeiting has been a hot topic in the news recently.  One company recently suspended as a defense contractor after a years-long investigation into its selling of counterfeit parts, Hong Dark Electronic Trade Company, provides a vivid glimpse into the counterfeiting industry as well as the specific risks the Department of Defense faces with the influx of fake parts. 

A memorandum from the Department of the Air Force revealed the vast impact that this single company had on the Department of Defense:

"Approximately 84,000 suspect counterfeit electronic parts purchased from Hong Dark entered the DoD supply chain, and many of these parts have been installed on DoD aircraft, including C-17, C-130J, C-27J, P-8A Poseidon, AH-64, SH-60B, and CH-46."

Additionally, a background memo submitted to a November, 2011 hearing before the Senate Armed Services Committee  contained the following description of the counterfeiting process:

"Much of the raw material of counterfeit electronic parts is salvaged electronic waste (e-waste) shipped from the U.S. and the rest of the world to Hong Kong. From Hong Kong, waste is trucked to cities in mainland China, such as the counterfeiting district of Shantou in Guangdong Province, where electronic parts may be burned off of old circuit boards, washed in the river, and dried on city sidewalks. Once washed and sorted, parts may be sanded down to remove the existing part number, date code (which tells you when a part was made), and other identifying marks. In a process known as “black topping,” the tops of the parts may be recoated to hide those sanding marks. State of the art printing equipment may then be used to put false markings on the parts. When the process is complete the parts can look brand new."

Legitimate microchip manufacturers operate highly controlled environments, investing billions of dollars "in state-of-the-art facilities and take extreme precautions to prevent particles of dust, moisture, or other elements from damaging their products." Comparing this process to the one "used by counterfeiters, where chips may be burned off boards, washed in dirty rivers, dried on the ground, and remarked with newer or different part numbers," it is easy to see the risk that these parts pose. 

Unfortunately, the defense industry is particularly vulnerable to the flood of counterfeit parts. The director of the DOD’s Microelectronics Activity Unit explained, "The defense community is critically reliant on a technology that obsoletes itself every 18 months, is made in unsecure locations and over which we have absolutely no market share influence." The nature of the risk combined with the defense industry's particular vulnerability to counterfeit parts helps explain the push for increased accountability at all steps in the defense industry supply chain. 

Aeolus ($AOLS): BARDA Extends Contract for AEOL 10150 (Acute Radiation Syndrome)

The world of BioDefense remains murky as an investment vehicle among biotechnology companies. The danger from a dirty bomb or outright nuclear blast is unimaginable. One company working to develop a Medical Counter Measure is Aeolus (AOLS).  Valuation is low and grant level is high.

From the Aeolus Pharmaceuticals, Inc. (OTCQB: AOLS) press release: AOLS is a biotechnology company leveraging significant government funding to develop a platform of novel compounds in oncology and biodefense, today announced that the Company has entered into a contract modification and no-cost extension with the Biomedical Advanced Research and Development Authority (BARDA), part of the Department of Health and Human Services (HHS). The modification and extension will allow the Company to continue operating under the base period of the contract awarded last February, and restructures the timing and components of the options that can be awarded under the remaining four years of the agreement. The changes do not impact the total potential value of the contract, which remains at approximately $118 million. The Aeolus contract is for the advanced development of AEOL 10150 as a medical countermeasure (MCM) against the pulmonary sub-syndrome of acute radiation syndrome (ARS).

Through the end of January 2012, Aeolus had billed or completed approximately $7.9 million of programs under the contract, had committed work in progress totaling approximately $2.0 million and expected to bill for the full amount of $10.4 million in the base period Under terms of this cost plus, fixed fee development contract, Aeolus will receive $10.4 million in the base period of performance and up to an additional $107.5 million in options, if exercised by BARDA, for a total contract value of up to $118 million. In addition to accomplishing the major objectives during the base period of the agreement, Aeolus managed the contract so that 12 additional items could be added to create further value for the government during the base period. The modification reflects these additional items, as well as the additional time required to complete them.

Aeolus will be presenting the results and deliverables that have been produced during the first twelve months under the base period of the contract at an "In-Progress Review" meeting with BARDA on February 14, 2012, and will be requesting the exercise of additional contract options, which contain the key items required in the advanced development of AEOL 10150 from April 2012 through March 2013. Among, these key items are efficacy studies in murine and non-human primate models, a Phase 1 clinical study in healthy normal volunteers, mechanism of action research and manufacturing and process validation work. All of these items build off of work successfully completed during the first twelve months of the contract base period.

"We have delivered significant value to shareholders and the government during the first twelve months of the BARDA contract and look forward to presenting this progress to BARDA next week, and making our case for the exercise of additional options. The threat of radiation exposure from nuclear accidents and/or nuclear attacks is unfortunately a reality, and AEOL 10150 represents a promising technology to protect our citizens from this threat. With the contract modification and the continued support of BARDA, we will take additional major steps forward in the development of AEOL 10150 as a countermeasure to the pulmonary effects of ARS," said John L. McManus, Chief Executive Officer and President of Aeolus Pharmaceuticals, Inc. "We are grateful for both the economic and intellectual support we have received from BARDA to advance the development of our drug, and as a result have made significant progress toward our ultimate objectives of procurement and FDA approval, while creating jobs and supporting more than 35 full-time equivalent positions."

About the BARDA Contract

In addition to supporting the cost of development of AEOL 10150 as an MCM for Lung ARS, the Company believes that the preclinical, chemistry, manufacturing, and controls (CMC), toxicology, and safety studies expected to be performed under the BARDA contract will be supportive of the Company's oncology development program. A procurement of AEOL 10150 for the Strategic National Stockpile could occur after approval from the U.S. Food and Drug Administration, if obtained, or sooner under an Emergency Use Authorization (EUA). The value of a procurement, if any, is not included in the contract value announced herein.

AEOL 10150 is currently also being studied by the National Institutes of Health's (NIH) National Institute of Allergy and Infectious Diseases (NIAID) Radiation/Nuclear Medical Countermeasures development program as a countermeasure for radiation exposure to the gastrointestinal tract and by NIH CounterACT as countermeasure against chlorine gas and sulfur mustard gas exposure.

About Acute Radiation Syndromes (ARS)

Immediately after exposure, the most critical components of acute radiation syndrome are the hematopoietic (bone marrow) and early-onset gastrointestinal (GI) syndromes because symptoms begin very quickly and can be lethal. However, depending on the level and location of radiation exposure, much of the lethality of both hematopoietic and early-onset gastrointestinal syndromes are potentially avoidable with proper treatment, including supportive care (fluids and antibiotics) and Neupogen, leaving complications to later responding tissues subsequently becoming a major problem.

In situations of accidental exposure, it was initially assumed that a whole-body dose exceeding 10 Gy was inevitably fatal. However, experience with nuclear accident victims suggests that when patients survive gastrointestinal and bone marrow syndromes, respiratory failure become the major cause of death. This effect is known as a delayed effect of acute radiation exposure (DEARE).

About Cancer Radiation Therapy

According to the American Cancer Society, cancer is the second leading cause of death by disease representing one out of every four deaths in the United States. According to the Radiological Society of North America, about 50 to 60 percent of cancer patients are treated with radiation at some time during their disease. The NIH estimates overall costs of cancer in 2008 in the United States at $228.1 billion: $93.2 billion for direct medical costs, $18.8 billion for indirect morbidity costs (costs of lost productivity due to illness) and $116.1 billion for indirect mortality costs (cost of lost productivity due to premature death).

About BARDA

The Biomedical Advanced Research and Development Authority (BARDA), within the Office of the Assistant Secretary for Preparedness and Response in the U.S. Department of Health and Human Services, provides an integrated, systematic approach to the development and purchase of the necessary vaccines, drugs, therapies, and diagnostic tools for public health medical emergencies. BARDA was established to provide funding and coordination to address challenges in medical countermeasure development. BARDA was created to increase funding for advanced research and development and to better coordinate the U.S. government's medical countermeasure development and acquisition process. BARDA manages Project BioShield, which includes the procurement and advanced development of medical countermeasures for chemical, biological, radiological, and nuclear agents, as well as the advanced development and procurement of medical countermeasures for pandemic influenza and other emerging infectious diseases that fall outside the scope of Project BioShield.

About AEOL 10150

AEOL 10150 is a broad-spectrum catalytic antioxidant specifically designed to neutralize reactive oxygen and nitrogen species. The neutralization of these species reduces oxidative stress, inflammation, and subsequent tissue damage-signaling cascades resulting from radiation exposure. The Company believes that AEOL 10150 could have a profound beneficial impact on people who have been exposed, or are about to be exposed, to high-doses of radiation in the treatment of oncology.

AEOL 10150 has already performed well in animal safety studies, was well-tolerated in two human clinical trials, and has demonstrated statistically significant survival efficacy in an acute radiation-induced lung injury model. AEOL 10150 is also currently in development for use as both a therapeutic and prophylactic drug in cancer patients.

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Soligenix (SNGXD): Acute Radiation Syndrome (ARS)-GI, Shows Positive Data

Soligenix (OTCBB: SNGXD) announced results from its phase 1/2 clinical trial of SGX201 for the prevention of acute radiation enteritis. The press release covers how the study demonstrated that oral administration of SGX201 (beclomethasone) was safe and well tolerated across all four dose groups.

There was also evidence of a potential dose response with respect to diarrhea, nausea, and vomiting and the assessment of enteritis according to NCI Common Terminology Criteria for Adverse Events for selected gastrointestinal events. In addition, the incidence of diarrhea was lower than that seen in recent published historical control data in this patient population.

CBS NY - Applied DNA's ($APDN) Digital DNA’ May Soon Be Required To Take SAT And ACT Exams

Applied DNA Sciences Inc. (OTCBB: APDN; Twitter: $APDN) sells patented DNA security solutions to protect products, brands and intellectual property from counterfeiting and diversion. SigNature DNA is a botanical mark used to authenticate products in a unique manner that essentially cannot be copied, and provide a forensic chain of evidence that can be used to prosecute perpetrators.

On Monday, CBS New York’s Jennifer McLogan reported on what politicians will see first hand in Albany this afternoon, and what could soon be implemented in New York and at high schools around the country.

Inside the Applied DNA Sciences lab at Stony Brook University researchers are hard at work inventing and perfecting a system that can prevent cheating on SAT and ACT exams.

“A novel system that’s absolutely unbreakable for securing the identity of a student taking the SAT exam,” said Dr. James Hayward.

Applied DNA put out a press release this morning in anticipation of today's hearing which states:

Dr. James A. Hayward, President and CEO of Applied DNA Sciences, Inc. (OTC.BB: APDN.OB - News), has been invited by the Chairman of the New York Senate Higher Education Committee to speak about APDN's digitalDNA™ technology to help block cheating on standardized tests such as the SAT college entrance exam. The Chairman, State Senator Kenneth LaValle, has been pressing for a solution since dozens of individuals were arrested on Long Island last November for paying others to take the tests for them.

At least four test-takers have been accused of accepting cash payments of $500 to $3,600 to take the test for students, largely from Long Island's North Shore schools.

In his testimony, Dr. Hayward will detail how APDN's digitalDNA can aid in preventing a reoccurrence of the cheating scandal.

In a TV interview with CBS News on January 23, Dr. Hayward demonstrated the technology he called "a novel system that is absolutely unbreakable for students taking the SAT exams."

(A video clip of the interview may be found here, the CBS news story here).

The digitalDNA system creates a counterfeit-proof, secure ID card. The card is embedded with infinitesimal molecules of plant DNA segments that authenticate a student's identity in a way that is absolutely uncopyable. The anti-counterfeiting technology also features a scannable printed code, which visually represents the same identity information. Embedded within the iconic code, and in covert locations on the card, is the physical code of digitalDNA. A scan, using a Smartphone or other mobile device, may be done instantly for exam-screening purposes, or at any other point. If deemed necessary, a second level of screening is available: the plant DNA on the card may be swabbed and forensically evaluated; a system well-recognized by courts globally.

All information is sent wirelessly to, and stored in, an ultra-secure internet database in "a private cloud." Applied DNA Sciences is closely affiliated with Stony Brook University's Center of Excellence in Wireless & Information Technology.

In his planned testimony, Dr. Hayward comments:

"Botanical DNA markers transform SAT identification cards into robust evidentiary tools that can assist in criminal prosecution efforts. The challenge is to ensure that actual, eligible, registered participants complete their exams. The goal is preserving exam integrity and maintaining a level playing field for all participants, and the solution is enhanced preregistration in tandem with identity verification before and after exams. We are confident that digitalDNA can assist in achieving the goal of an effective, easy-to-use and affordable system for preventing testing fraud."

Applied DNA Sciences is well-known throughout Europe and the U.S. for using botanical DNA to create very high security anti-counterfeiting systems. Such a system, now being piloted by an agency of the Department of Defense, identifies counterfeit microchips before they make their way into the U.S. military supply chain. Product authentication using botanical DNA has proved to be virtually uncopyable and resistant to the most highly stressed environment -- a must for the military.

APDN has installed its products in Europe and the U.S., protecting banks and ATMs (U.S.), jewelry stores (Sweden), and cash-in-transit strong boxes (UK). Its Signature DNA cash-protection system has won two top policing prizes in the United Kingdom over the past two years for successful work with police in helping secure convictions of cash thieves.

The State Senate hearing on SAT cheating is scheduled for January 24th, between the hours of 12:00PM and 3:00PM Eastern Time in the Legislative Office Building, Hearing Room A in Albany, New York. This event will also be streamed live on the NY Senate, Committee on Higher Education webpage found at: http://www.nysenate.gov/committee/higher-education

SmartDNA to protect banks and ATMs, turn criminals into chumps; $APDN

Applied DNA Sciences Inc. (OTCBB: APDN; Twitter: $APDN) sells patented DNA security solutions to protect products, brands and intellectual property from counterfeiting and diversion. SigNature DNA is a botanical mark used to authenticate products in a unique manner that essentially cannot be copied.

One of APDN's products is SmartDNA, an intruder/offender tagging system. SmartDNA intruder/offender tagging devices are installed in retail locations, banks, industrial facilities - any place where the goal is to protect against theft or vandalism. If a crime is committed, the SmartDNAsystem is armed manually or through a central security system. When the intruder passes near the device, he is tagged with a DNA-marked spray that makes establishing crime linkage definitive. The DNA-marked spray provides a forensic chain of evidence that can be used to prosecute perpetrators...

...like this guy:

Criminals, you've been warned: hooded jackets and furtive moves are no match for DNA authentication.